A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

Part of paid clinical trials in Hialeah, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT04407234
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Tirzepatide administered SC.
  • Acetaminophen — DRUG
    Acetaminophen administered orally.

Study Details

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening.

Key Dates

Start date
Sep 15, 2020
Status verified
Apr 2023
Primary completion
Jan 7, 2021
Completion
Jan 7, 2021

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide + Acetaminophen
    Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen [ Time Frame: Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiHialeahFlorida33014-

Find similar trials in Hialeah, FL

By condition
Type 2 diabetesObesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Clinical Pharmacology of Miami· Hialeah, FL

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